Representative batches? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2010-08-04 23:42 (4308 d 06:53 ago) – Posting: # 5719
Views: 14,430

Dear ElMaestro,

nice summary; couldn’t agree more.
Section 4.1.2 of the BE-GL: “representative” appears three times and “justify/justification” five times. ;-)

In the past sponsors tried to select T & R batches which matched closely in vitro (content & dissolution). If BE could be demonstrated, everybody was happy (believing that the “selection” worked). If not, most people did rather not question the (lacking) discriminatory power of the in vitro method, but sighed and said “Well, we have to face that it did not work in in vivo – but it’s well known, that without IVIVC, etc. etc.”

I have strong doubts that it is possible to justify that a batch is representative – if we move away from pharmaceutical quality and start thinking about BE.

I changed the category; doesn’t look as a statistical issue to me (any more). [Helmut]

Dif-tor heh smusma 🖖 [image]
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
 Admin contact
22,091 posts in 4,630 threads, 1,566 registered users;
online 8 (0 registered, 8 guests [including 4 identified bots]).
Forum time: Sunday 06:36 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz